Davita Teterboro Dialysis

“Local, State, Tribal Collaboration Process CFR(s): §403.748(a)(4), §416.54(a)(4), §418.113(a)(4), §441.184(a)(4), §460.84(a)(4), §482.15(a)(4), §483.73(a)(4), §483.475(a)(4), §484.102(a)(4), §485.68(a)(4), §485.542(a)(4), §485.625(a)(4), §485.727(a)(5), §485.920(a)(4), §486.360(a)(4), §491.12(a)(4), §494.62(a)(4) [(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years [annually for LTC facilities]. The plan must do the following:] (4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials’ efforts to maintain an integrated response during a disaster or emergency situation. * * [For ESRD facilities only at §494.62(a)(4)]: (4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials’ efforts to maintain an integrated response during a disaster or emergency situation. The dialysis facility must contact the local emergency preparedness agency at least annually to confirm that the agency is aware of the dialysis facility’s needs in the event of an emergency. This Standard is not met as evidenced by: 30177 Based on interview, document review, and review of the facility’s “Emergency Management Plan,” it was determined that the facility failed to communicate annually with the local emergency preparedness agency to confirm the agency’s awareness of the dialysis center’s needs during an emergent event. This failure has the potential to delay care and treatment and other sources of assistance to the 41 in-center hemodialysis patients receiving treatments at this facility. Findings include: Review of the facility’s undated “Emergency Management Plan,” revised in April 2023, revealed, “The Facility Administrator, or designee, shall have communication at least on an annual basis with the Local Emergency Management agency regarding emergency preparedness, event collaboration and communication, needs of the dialysis patients and facility, and reviewing agency’s emergency plan. NOTE:. . .documentation of contact is important.” In an interview on 01/16/24 at 10:53 AM, a request was made to the Facility Administrator to provide documentation confirming the local emergency preparedness agency was contacted to confirm that the agency is aware of the dialysis facility’s needs in the event of an emergency. The Facility Administrator revealed there was no documented evidence of contact or communication with the local office of emergency. The Facility Administrator confirmed the facility is required to contact the local emergency preparedness agency annually.”

“PE-EQUIPMENT MAINTENANCE-MANUFACTURER’S DFU CFR(s): 494.60(b) The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer’s recommendations. This Standard is not met as evidenced by: 30177 Based on observation, staff interview, policy review, and manufacturer’s directions for use (MDFU) review, it was determined that the facility failed to ensure staff followed the IFU and facility policy for the specific bloodlines in use during hemodialysis (an artificial means of kidney function that removes the waste and excess fluid from the blood by passing it through a filter) treatments in that the staff failed to correctly position and monitor the arterial and venous “pressure oscillating devices” (PODs) for membrane rupture every 30 minute. Failure to follow the IFU and facility policy has the potential for an air embolus or blood leak to go unnoticed and may result in serious complications, including blood loss due to clotting or air entering the bloodstream. This failure places the 41 patients receiving in-center hemodialysis treatments at this facility at risk for adverse outcomes. Findings include: Interview during observations on 01/17/24 at 10:00 AM, with the Facility Administrator and the Manager of Clinical Services, revealed that five of five hemodialysis stations (4, 9, 11, 13, and isolation), the POD located on the bloodlines were incorrectly positioned during hemodialysis treatment and confirmed by the Facility Administrator. During an interview on 01/17/24 at 10:00 AM, Registered Nurse (RN)10 revealed the facility utilizes “Streamline Airless System” bloodline sets. RN10 was asked to provide documentation that the Streamline bloodlines PODs on the isolation station and stations 4, 9, 11, and 13 were monitored every 30 minutes. RN10 replied, “We don’t actually document it and there is no documentation to show.” During an interview on 01/17/24 at 10:15 AM, Patient Care Technician (PCT)1 was asked to provide documentation that the Streamline bloodlines PODs on the isolation station and stations 4, 9, 11, and 13 were monitored every 30 minutes. PCT1 replied, “I don’t have any documentation. We don’t document on the PODs.” An interview with the Facility Administrator on 01/17/24 at 11:00 AM revealed he/she stated staff were trained on monitoring the arterial and venous PODs every 30 minutes during treatment for membrane rupture and correct positioning of the PODs. The Facility Administrator was then asked if the flexible diaphragm should be visible and the dome side of the POD should be facing outward; He/she replied, “Yes.” A review of the “Streamline Airless System” bloodlines MDFU revealed, “Monitor each POD continually for blood or air leaks through its flexible diaphragm. If POD or diaphragm leaks, stop the blood pump immediately. If blood reaches the dialysis machine’s pressure port, the machine must be taken out of service and disinfected and/or cleaned per the Fresenius 2008 machine operator’s manual. Ensure each POD flexible diaphragms are in correct position. Positioned arterial POD dome facing outward from machine face. Arterial diaphragm curve is against dome side of the POD. Venous diaphragm curve is away from dome side at base of POD.” A review of the facility’s policy titled, “Center Without Walls (CWOW) Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment,” revised April 2021, revealed that “Intradialytic treatment monitoring and data collection which may be performed by the patient Care Technician or licensed nurse includes ... If Streamline blood lines are used, the arterial and venous PODs should be observed every 30 minutes to verify there has been no POD membrane rupture. If POD membrane rupture occurs, the whole Streamline blood line needs to be changed...” N.J.A.C. 8:43A-24.4(a)”